Physiological ResponsesNCT05208008
Effect of Owning a Service Dog on Military Veterans With PTSD
An observational study of Physiological Responses and Sleep Disorders, Circadian Rhythm, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiological Responses, Sleep Disorders, Circadian Rhythm, Stress, Emotional
- What is being tested?
- With service dog
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Military veterans, that either already ave a certified service dog, or are approved to receive a certified service dog, but on a waitlist. Furthermore, the military veterans should fulfill the inclusion criteria. The are recruited with help from the Danish Military, and the initial contact is established when potential participants respond to the advertisements by contacting of the scientific staff of the project.
Who may be able to join
- Have been deployed in a war zone
- Fulfil criteria for PTSD
- Fulfil criteria for receiving a certified service dog
- If having a service dog, they must have owned the dog for more than 6 months, and the dog must be at leat 2 years of age
Who cannot join
- Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.
Read the detailed description
The investigators will measure and compare the immediate effect of the presence of the dog, on days with low stress and high stress, using non-invasive measures of the physiological response, diary notes, and data on activity and sleep pattern The latter will also be collected for the service dogs. The investigators will apply a cross-sectional design. The participants will be divided into two groups based on whether they own a certified service dog (treatment group) or are on a waitlist for a service dog (control group).
The experimental period will consist of a 14-day period. In the preceding week the participants receive a visit, where they will be given instructions to fill in a diary, how to collect and store saliva samples, and use equipment for data collection. In the diary they record their daily activities and any situation perceived to be stressful during the experimental period. In the experimental period, the participants will wear an accelerometer. Every second day, the particpants will wear equipment measuring their heart rate.
- Being tested
- With service dog
- Keywords
- Human-animal contact, Non-invasive measure
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With service dogOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| With service dog | Veterans living with a certified service dog Receives: Other: With service dog | |
| Without service dog | Veterans living without a certified service dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily activity pattern
Daily activity pattern measured with a wrist-worn accelerometer
Measured: In the experimental period, which is 14 days
Sleep pattern
Sleep pattern measured with a wrist-worn accelerometer
Measured: In the experimental period, which is 14 days
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 1 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 1 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 2 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 2 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 3 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 3 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 4 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 4 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 5 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 5 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 6 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 6 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 7 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 7 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 8 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 8 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 9 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 9 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 10 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 10 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 11 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 11 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 12 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 12 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 13 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 13 of the experimental period at 8 p.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 14 of the experimental period at 11 a.m.
Salivary, Cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Day 14 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 1 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 1 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 2 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 2 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 3 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 3 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 4 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 4 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 5 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 5 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 6 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 6 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 7 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 7 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 8 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 8 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 9 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 9 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 10 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 10 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 11 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 11 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 12 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 12 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 13 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 13 of the experimental period at 8 p.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 14 of the experimental period at 11 a.m.
Blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Day 14 of the experimental period at 8 p.m.
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 2 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 4 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 6 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 8 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 10 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 12 of the experimental period
Heart rate
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Measured: Day 14 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 2 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 4 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 6 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 8 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 10 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 12 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Measured: Day 14 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 1 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 2 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 3 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 4 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 5 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 6 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 7 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 8 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 9 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 10 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 11 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 12 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 13 of the experimental period
Dairy notes regarding stressful events
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Measured: Day 14 of the experimental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start17 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ResponsesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208008
- Sponsor's protocol ID
- ANIMAL CONTACT 3
- Status last verified
- May 2023
- First submitted
- 20 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
- ClinicalTrials.gov ID
- NCT05208008
- Acronym / sponsor ID
- ANIMAL CONTACT 3
- Keywords
- Human-animal contact, Non-invasive measure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.
Detailed description
The investigators will measure and compare the immediate effect of the presence of the dog, on days with low stress and high stress, using non-invasive measures of the physiological response, diary notes, and data on activity and sleep pattern The latter will also be collected for the service dogs. The investigators will apply a cross-sectional design. The participants will be divided into two groups based on whether they own a certified service dog (treatment group) or are on a waitlist for a service dog (control group).
The experimental period will consist of a 14-day period. In the preceding week the participants receive a visit, where they will be given instructions to fill in a diary, how to collect and store saliva samples, and use equipment for data collection. In the diary they record their daily activities and any situation perceived to be stressful during the experimental period. In the experimental period, the participants will wear an accelerometer. Every second day, the particpants will wear equipment measuring their heart rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With service dog | – | Other: With service dogVeterans living with a certified service dog |
| Without service dog | – | –Veterans living without a certified service dog |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Military veterans, that either already ave a certified service dog, or are approved to receive a certified service dog, but on a waitlist. Furthermore, the military veterans should fulfill the inclusion criteria. The are recruited with help from the Danish Military, and the initial contact is established when potential participants respond to the advertisements by contacting of the scientific staff of the project.
Key inclusion criteria (4 listed)
- Have been deployed in a war zone
- Fulfil criteria for PTSD
- Fulfil criteria for receiving a certified service dog
- If having a service dog, they must have owned the dog for more than 6 months, and the dog must be at leat 2 years of age
Key exclusion criteria (1 listed)
- Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With service dogNo intervention | Other | With service dog |
Primary outcome
Daily activity pattern
Time frame: In the experimental period, which is 14 days
Daily activity pattern measured with a wrist-worn accelerometer
Sleep pattern
Time frame: In the experimental period, which is 14 days
Sleep pattern measured with a wrist-worn accelerometer
Salivary, Cortisol
Time frame: Day 1 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 1 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 2 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 2 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 3 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 3 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 4 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 4 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 5 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 5 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 6 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 6 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 7 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 7 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 8 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 8 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 9 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 9 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 10 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 10 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 11 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 11 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 12 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 12 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 13 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 13 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 14 of the experimental period at 11 a.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Salivary, Cortisol
Time frame: Day 14 of the experimental period at 8 p.m.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Blood pressure
Time frame: Day 1 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 1 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 2 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 2 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 3 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 3 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 4 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 4 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 5 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 5 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 6 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 6 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 7 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 7 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 8 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 8 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 9 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 9 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 10 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 10 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 11 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 11 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 12 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 12 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 13 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 13 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 14 of the experimental period at 11 a.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Blood pressure
Time frame: Day 14 of the experimental period at 8 p.m.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Heart rate
Time frame: Day 2 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 4 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 6 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 8 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 10 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 12 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate
Time frame: Day 14 of the experimental period
The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Heart rate variability
Time frame: Day 2 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 4 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 6 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 8 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 10 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 12 of the experimental period
Heart rate variability is calculated from heart rate data
Heart rate variability
Time frame: Day 14 of the experimental period
Heart rate variability is calculated from heart rate data
Dairy notes regarding stressful events
Time frame: Day 1 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 2 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 3 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 4 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 5 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 6 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 7 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 8 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 9 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 10 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 11 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 12 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 13 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Dairy notes regarding stressful events
Time frame: Day 14 of the experimental period
The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Responses and Sleep Disorders, Circadian Rhythm, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily activity pattern (time frame: In the experimental period, which is 14 days). The study lists 86 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.